Identity
- Trade Name
- Fuse ULTRA Foot plating System FDA UDI
- Generic Name
- Bone tap, reprocessed FDA UDI
- Device Name
- Small Compressor Distractor Assembly FDA UDI
- Model / Reference
- OS423019 FDA UDI
- Description
- Small Compressor Distractor Assembly FDA UDI
Identifiers
- Catalog Number
- OS423019 FDA UDI
- Primary DI / UDI-DI
- B565OS4230191 FDA UDI
- 510(k) Number
- K141784 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Bone tap, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Bone tap, reprocessed
Fuse ULTRA Foot plating System by CPM Medical Consultants, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone tap, reprocessed.
- Altus Spine Pedicle Screw System — Altus Spine · Class II
- Altus Spine Pedicle Screw System — Altus Spine · Class II
- Altus Spine Pedicle Screw System — Altus Spine · Class II
- Brickyard Stand-Alone ALIF — Altus Spine · Class I
- Sochi — Altus Spine · Class II
- Brickyard Stand-Alone ALIF — Altus Spine · Class II
- Altus Spine Pedicle Screw System — Altus Spine · Class II
- Altus Spine Pedicle Screw System — Altus Spine · Class II
Cleared under the same submission
K141784 also covers:
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA FOOT PLATING SYSTEM — CPM Medical Consultants, LLC
- Fuse ULTRA Foot plating System — CPM Medical Consultants, LLC
- Fuse ULTRA Foot plating System — CPM Medical Consultants, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CPM Medical Consultants, LLC
Sources (1)
- FDA UDI 40a057fa-7c97-4eba-8b73-87cbd61c9f05 36 fields · synced May 30, 2026